The number of wounds and market for products promoting wound healing is substantial and rising. Over 110 million iatrogenic wounds, wounds that are either induced or caused by a medical procedure, are created every year, while an estimated 20 million patients seek medical attention for traumatic wounds.
Difficult to heal and chronic wounds, including pressure ulcers, venous ulcers, and diabetic ulcers are growing in incidence every year due to the aging of the population. Approximately 8.5 million patients world wide suffer from pressure ulcers, an estimated 12.5 million patients suffer from venous ulcers, and approximately 13.5 million patients suffer from diabetic ulcers. The associated morbidities and mortalities are also very significant and increasing. For example, non-healing diabetic ulcers not only affect patient mobility but are a leading cause of amputations in the U.S. and many other industrialized countries. Approximately 50% of such amputees die from associated co-morbidities within three years of amputation.
In the case of the diabetic foot ulcers, the current Standard of Care (SOC) includes surgical debridement, moist dressing changes, and off-loading. Currently available secondary interventions include living skin equivalents, hyperbaric oxygen, negative pressure devices, antibiotics for infection, specialized dressings, or a topical gel containing growth factors or collagen. Such secondary interventions provide moderate improvement over the SOC and can be expensive, time consuming, and/or difficult to use. In addition, despite these interventions, many wounds do not heal and may worsen to the point where an amputation becomes necessary. There remains a need for an easy to use and effective treatment of these and other wounds.
The present invention relates generally to formulations of atelopeptide tropocollagen matrices and uses of such formulations for promoting healing and tissue repair and/or regeneration in wounds induced by, for example, trauma or injury, a disease state, bed sores, or surgery.